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Transversus Abdominis Plane Block Versus Quadratus Lumborum Block in The Pediatric Population Undergoing Orchiopexy

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transversus abdominis plane block, Quadratus lumborum block
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Postoperative focused on measuring quadratus lumborum block, transversus abdominis plane block, pediatric patient, orchiopexy, regional anesthesia, pain

Eligibility Criteria

6 Months - 12 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA physical status I-III
  • Undergoing elective unilateral orchiopexy

Exclusion Criteria:

  • Not giving a consent
  • ASA physical status IV
  • Need to postoperative ICU care
  • History of allergic reactions to anesthetics
  • Infection at the injection site
  • Laparoscopic Orchiopexy

Sites / Locations

  • Istanbul University - Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Quadratus Lumborum Block

Transversus Abdominis Plane Block

Arm Description

After the premedication with ketamine and midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both groups and the local anesthetic agent will be administrated with ultrasound at the anterolateral border of quadratus lumborum muscle with 18, 20 or 22 Gauge IV Cannula (Bicakcilar Cooperation, Istanbul, Turkey) according to age and body weight.

After the premedication with ketamine and midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both groups and the local anesthetic agent will be administrated with ultrasound between internal oblique and transversus abdominis muscle with 18, 20 or 22 Gauge IV Cannula (Bicakcilar Cooperation, Istanbul, Turkey) according to age and body weight.

Outcomes

Primary Outcome Measures

Total Analgesia Consumption
The required analgesic consumption within the framework of the predetermined protocol will be recorded by the nurses and doctors who do not know which block is used. After discharge, the family will be called by phone to find out the amount of additional analgesic need.
The Effect on Perioperative and Postoperative Pain
The investigator will screen and record perioperative hemodynamic parameters for the perioperative pain evaluation. The Face, Legs, Activity, Cry, Consobility (FLACC) Score will be used for evaluation of the postoperative pain. The FLACC pain assessment score is evaluated out of 10 points. While a score of zero defined as no pain, 1-3 is mild pain, 4-6 is moderate pain, 7-10 is severe pain, respectively. If the score is 4 and above, additional analgesic administration will be planned.
The Effect on Post-discharge Pain
Post-discharge pain will be assessed by the Wong Baker Score. Pain will be evaluated based on six facial expressions between zero and ten points. If the score is four or more, additional analgesic administration will be planned.

Secondary Outcome Measures

Parent satisfaction score
At the postoperative 24th hour, the investigator will ask to the parents by telephone visit. Parent satisfaction score is defined as unsatisfied (1), partially satisfied (2), satisfied (3)

Full Information

First Posted
May 29, 2019
Last Updated
June 5, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT03969316
Brief Title
Transversus Abdominis Plane Block Versus Quadratus Lumborum Block in The Pediatric Population Undergoing Orchiopexy
Official Title
The Comparison of Ultrasound-Guided Transversus Abdominis Plane Block and Quadratus Lumborum Block in The Pediatric Population Undergoing Orchiopexy. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
December 18, 2020 (Actual)
Study Completion Date
March 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Transversus abdominis plane (TAP) and Quadratus lumborum (QL) blocks are used for the management of acute pain treatment, especially after the lower and upper abdominal surgeries. The TAP block which is one of the abdominal truncal blocks is performed with the blockage of the nerve group which innervates the anterior abdominal muscle wall layers. However, in QL block, the local anesthetic agent spreads through the abdominal wall and paravertebral space with the help of the perimuscular fascia to maintain the somatic analgesia. The investigators' aim in this study, to investigate the effect of the TAP and QL blocks on peroperative and postoperative analgesic consumption in children undergoing unilateral elective orchiopexy.
Detailed Description
American Society of Anesthesiologists Physical Status Classification System (ASA) class I-III, aged 6 month-12 years old children undergoing unilateral elective orchiopexy with general anesthesia will be recruited, after the informed consent will be obtained from the parents of the patients, in this randomized controlled trial. After the premedication with ketamine and midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane. Subsequently, before the surgery, the patients will be randomized and separated into 2 groups. The investigators will apply the QL block to the first group and TAP block to the other group. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both group. In the peroperative period, if the additional analgesia will necessary, remifentanyl 0.1mcg/kg/min will be started, and dosage will be adjusted according to heart rate and blood pressure. If the blood pressure or heart rate will increase more than 20% from the preoperative basal value will be defined as the need for the analgesia. In the postoperative period, all cohort will be assessed by a blinded investigator at the 10,20,30th minutes, 1,2nd hours in the recovery room, 6th hour in the surgical ward, Face, Legs, Activity, Cry, Consolability Scale (FLACC) will be used for the pain evaluation. 16th and 24th hours will be monitored by the telephone visit from the parents, the pain will be evaluated with the Wong-Baker Faces Pain Rating Scale due to the same-day surgery concept.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
quadratus lumborum block, transversus abdominis plane block, pediatric patient, orchiopexy, regional anesthesia, pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadratus Lumborum Block
Arm Type
Active Comparator
Arm Description
After the premedication with ketamine and midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both groups and the local anesthetic agent will be administrated with ultrasound at the anterolateral border of quadratus lumborum muscle with 18, 20 or 22 Gauge IV Cannula (Bicakcilar Cooperation, Istanbul, Turkey) according to age and body weight.
Arm Title
Transversus Abdominis Plane Block
Arm Type
Active Comparator
Arm Description
After the premedication with ketamine and midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both groups and the local anesthetic agent will be administrated with ultrasound between internal oblique and transversus abdominis muscle with 18, 20 or 22 Gauge IV Cannula (Bicakcilar Cooperation, Istanbul, Turkey) according to age and body weight.
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane block, Quadratus lumborum block
Intervention Description
The TAP block which is one of the abdominal truncal blocks is performed with the blockage of the nerve group which innervates the anterior abdominal muscle wall layers. However, in QL block, the local anesthetic agent spreads through the abdominal wall and paravertebral space with the help of the perimuscular fascia to maintain the somatic analgesia.
Primary Outcome Measure Information:
Title
Total Analgesia Consumption
Description
The required analgesic consumption within the framework of the predetermined protocol will be recorded by the nurses and doctors who do not know which block is used. After discharge, the family will be called by phone to find out the amount of additional analgesic need.
Time Frame
24 hour
Title
The Effect on Perioperative and Postoperative Pain
Description
The investigator will screen and record perioperative hemodynamic parameters for the perioperative pain evaluation. The Face, Legs, Activity, Cry, Consobility (FLACC) Score will be used for evaluation of the postoperative pain. The FLACC pain assessment score is evaluated out of 10 points. While a score of zero defined as no pain, 1-3 is mild pain, 4-6 is moderate pain, 7-10 is severe pain, respectively. If the score is 4 and above, additional analgesic administration will be planned.
Time Frame
24 hour
Title
The Effect on Post-discharge Pain
Description
Post-discharge pain will be assessed by the Wong Baker Score. Pain will be evaluated based on six facial expressions between zero and ten points. If the score is four or more, additional analgesic administration will be planned.
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Parent satisfaction score
Description
At the postoperative 24th hour, the investigator will ask to the parents by telephone visit. Parent satisfaction score is defined as unsatisfied (1), partially satisfied (2), satisfied (3)
Time Frame
24 hour

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status I-III Undergoing elective unilateral orchiopexy Exclusion Criteria: Not giving a consent ASA physical status IV Need to postoperative ICU care History of allergic reactions to anesthetics Infection at the injection site Laparoscopic Orchiopexy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozgecan P Zanbak, MD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayse C Tutuncu, MD,Prof
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University - Cerrahpasa
City
Istanbul
ZIP/Postal Code
34100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28154824
Citation
Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
Results Reference
background
PubMed Identifier
27755488
Citation
Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495. Erratum In: Reg Anesth Pain Med. 2018;43:111.
Results Reference
background
PubMed Identifier
28759502
Citation
Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
Results Reference
background

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Transversus Abdominis Plane Block Versus Quadratus Lumborum Block in The Pediatric Population Undergoing Orchiopexy

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